Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

University of Miami

Status: Completed

Conditions: Tetraplegia; Spinal Cord Injuries; Dietary Modification; Paraplegia; Metabolic Syndrome

Treatments: Behavioral: Diet; Device: Functional Electrical Stimulation Leg Cycle Ergometry

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03495986

6996 (Other Identifier)

20190659

R01HD091278-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

Full description

The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18-65 years of age (inclusive)
• Sex: male or female
• Women of child-bearing potential who agree to refrain from getting pregnant during the trial
• C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12 months
• <5% change in body weight over the past 12 months

Exclusion criteria

• <22% body fat
• Unresponsive to neurostimulation
• Those who have participated in an FES or ACE exercise program (>60 minutes/week) within the past 3 months
• Known orthopaedic limitations
• Coronary artery disease
• Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose>126 or HgbA1c>7.0)
• Uncompensated Hypothyroidism (Stable on medication >1 year or not on medication)
• Renal disease
• Uncontrolled autonomic dysreflexia, recent (within 3 months)
• Deep vein thrombosis
• Pressure ulcers > Grade II
• Decisional impairment
• Any potential causes of autonomic dysreflexia at the discretion of the PI
• Prisoners
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups, including a placebo group

Home-Based Exercise & Diet Group

Experimental group

Description:

16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention

Treatment:

Device: Functional Electrical Stimulation Leg Cycle Ergometry

Behavioral: Diet

Home-Based Diet Alone Group

Placebo Comparator group

Description:

Diet intervention

Treatment:

Behavioral: Diet